Comparison of MAG and Fish Oil Efficacy

NCT ID: NCT01797757

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-12-31

Brief Summary

A potential application for unstructured monoacylglycerol (MAG) containing long chain polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed, it is predictable that chronic consumption of Orlistat® led to a depletion of essential fatty acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a source of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects with other type of maldigestion/malabsorption. Potential applications of such concept are therefore related to disease conditions comprising low lipid digestion due to lipase activity insufficiency.

In the present study, in order to see the response information for eicosapentanoic acid (EPA) delivery, EPA will be provided either as a mixture of free monoacylglycerols or as triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under Orlistat® consumption will be analyzed.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: QUADRUPLE

Study Groups

Fish oil enriched with EPA + ORLISTAT

The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.

The Orlistat capsules of 120mg (except for groups 1 and 2). 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.

Group Type: ACTIVE_COMPARATOR

Fish oil enriched with EPA

Intervention Type: DIETARY_SUPPLEMENT

Orlistat

Intervention Type: DRUG

MAG-EPA

The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.

Group Type: ACTIVE_COMPARATOR

MAG-EPA oil

Intervention Type: DIETARY_SUPPLEMENT

MAG-EPA + ORLISTAT

The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.

The Orlistat capsules of 120mg (except for groups 1 and 2). 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.

Group Type: ACTIVE_COMPARATOR

MAG-EPA oil

Intervention Type: DIETARY_SUPPLEMENT

Orlistat

Intervention Type: DRUG

Fish oil enriched with EPA

The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.

Group Type: ACTIVE_COMPARATOR

Fish oil enriched with EPA

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Fish oil enriched with EPA

Intervention Type: DIETARY_SUPPLEMENT

MAG-EPA oil

Intervention Type: DIETARY_SUPPLEMENT

Orlistat

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-65
• Sex female
• Body Mass Index (BMI) ≥ 30kg/m2 and < 40kg/m2
• Subjects willing to undergo treatment with Orlistat® (Xenical).
• Having obtained her written informed consent before any study related procedure including the pre-inclusion period.

Exclusion Criteria

• Binge eating disorder
• Any other weight loss treatment(s) within the last 3 months
• Vegetarians
• History of metabolic, cardiovascular, hepatic or renal diseases
• Obstructed bile duct
• Diseases that could interfere with intestinal absorption History of abdominal / gastric surgery (except appendicectomy)
• Use of drugs or illicit substances
• Consumption of alcohol > 50 gr/week
• Any other clinically significant abnormalities on screening laboratory evaluation (creatinine, Na, K, urique acide, ASAT, ALAT, Ph. Alc., yGT, Glycemia, total cholesterol, HDL, LDL, triglycerides) concentrations > 2.5 fold normal range
• Pregnant or lactating mothers
• Allergy to fish oil or other components (for e.g., gelatin or excepients of the capsule)
• Use of any other supplements containing fish oil for the duration of the trial or 3 month before inclusion in trial.
• Smokers
• Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study
• Bleeding disorders
• Subject who cannot be expected to comply with the study procedures.
• Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vittorio Giusti, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV Centre Hospitalier Universitaire Vaudois

Locations

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

Cruz-Hernandez C, Destaillats F, Thakkar SK, Goulet L, Wynn E, Grathwohl D, Roessle C, de Giorgi S, Tappy L, Giuffrida F, Giusti V. Monoacylglycerol-enriched oil increases EPA/DHA delivery to circulatory system in humans with induced lipid malabsorption conditions. J Lipid Res. 2016 Dec;57(12):2208-2216. doi: 10.1194/jlr.P070144. Epub 2016 Oct 5.

Reference Type: DERIVED

PMID: 27707818 (View on PubMed)

Other Identifiers

10.29.NRC

Identifier Type: -

Identifier Source: org_study_id